BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2800178 · Received October 22, 2012

    Report

    Report Number
    9616099-2012-00604
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 15, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE REPORTED ADVERSE EVENT OF A STROKE: DOCUMENTATION IN WRITTEN PROGRESS NOTES FROM SUBJECT'S HOSPITAL CHART STATES RIGHT HEMISPHERIC EMBOLIC SHOWER CAUSED BY AORTIC ATHEROSCLEROSIS. THE EVENT WAS TREATED WITH HEPARIN, ASPIRIN, PLAVIX. THE PATIENT WAS "NEUROLOGICALLY AT BASELINE" IMMEDIATELY POST-PROCEDURE, AND DISCHARGE SUMMARY STATES SUBJECT "NEUROLOGICALLY IMPROVED" UPON DISCHARGE. AN MRI OF THE BRAIN REVEALED A PROGRESSIVE STROKE IN THE CENTRUM SEMIOVALE ON THE RIGHT SIDE. THERE ARE SEVERAL NEW LUNAR INFARCTS DISTRIBUTED IN BOTH HEMISPHERES. THE NEW LUNAR INFARCTS DISTRIBUTE INTO THE RIGHT FRONTAL, TEMPORAL, AND PAROTID OCCIPITAL DISTRIBUTION ON THE RIGHT SIDE AND THE LUNAR INFARCTS ON THE LEFT ARE DISTRIBUTED IN THE LEFT FRONTAL AND TEMPORAL AND OCCIPITAL DISTRIBUTION ON THE LEFT. THE FINDINGS WERE SUGGESTIVE FOR THROMBOEMBOLISM.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(6) REGISTRY, THE PATIENT EXPERIENCED A STROKE ONE DAY POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (R5) DESCRIBED AS MILDLY CALCIFIED AND MODERATELY TORTUOUS WITH AN 85% STENOSIS. THERE WAS THROMBUS NOTED WITHIN THE LESION. AN ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION WHICH WAS NOT PRE-DILATED. A PRECISE STENT WAS SUCCESSFULLY DEPLOYED FOLLOWED BY REMOVAL OF THE ANGIOGUARD AND UPON INSPECTION IT WAS NOTED THAT THERE WAS DEBRIS FOUND IN THE FILTER BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE NEXT DAY THE PATIENT SUFFERED A NEUROLOGICAL DEFICIT DESCRIBED AS BEHAVIORAL CHANGE AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE EVENT LASTED MORE THAN TWENTY FOUR HOURS BUT FULLY RESOLVED. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO WEEKS POST PROCEDURE WITH ASPIRIN PRESCRIBED. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. THE PATIENTS MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA, DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, CORONARY PERCUTANEOUS REVASCULARIZATION AND HYPERTENSION WITH HIGH RISK CRITERIA OF HIGH CERVICAL ICA LESIONS OR CCA LESIONS BELOW THE CLAVICLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15556958 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. ISCHEMIC STROKE/CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. IT CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL, PHARMACEUTICAL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) REGISTRY, THE PATIENT EXPERIENCED A STROKE ONE DAY POST INDEX PROCEDURE. THE PATIENT IS A (B)(6) MALE WHO WAS ENROLLED IN THE SAPPHIRE STUDY FOR STENTING OF THE CAROTID ARTERY. THE TARGET LESION LOCATION WAS THE PROXIMAL RIGHT INTERNAL CAROTID ARTERY (R5). THE VESSEL WAS DESCRIBED AS MILDLY CALCIFIED AND MODERATELY TORTUOUS. THERE WAS THROMBUS NOTED WITHIN THE LESION. THE RATE OF STENOSIS WAS 85%. AN ANGIOGUARD ((B)(4)/ LOT 71010510) EMBOLIC PROTECTION DEVICE WAS ADVANCED AND DEPLOYED DISTAL TO THE LESION. THE LESION WAS NOT PRE-DILATED. A PRECISE ((B)(4)/ LOT 15556958) STENT WAS SUCCESSFULLY DEPLOYED IN THE LESION. THE ANGIOGUARD WAS SAFELY REMOVED FROM THE PATIENT AND UPON INSPECTION IT WAS NOTED THAT THERE WAS DEBRIS FOUND IN THE FILTER BASKET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE NEXT DAY THE PATIENT SUFFERED A NEUROLOGICAL DEFICIT DESCRIBED AS BEHAVIORAL CHANGE AND WAS DIAGNOSED WITH AN ISCHEMIC STROKE. THE EVENT LASTED MORE THAN TWENTY FOUR HOURS BUT FULLY RESOLVED. THE PATIENT WAS DISCHARGED APPROXIMATELY TWO WEEKS POST PROCEDURE WITH ASPIRIN PRESCRIBED. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15556958

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R ANGIOGUARD ((B)(4)/ LOT 71010510)